BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE CXE VOLUMETRICINFUSION PUMP

    MDR report key: 1872972 · Received October 18, 2010

    Report

    Report Number
    6000001-2010-04153
    Event Type
    Malfunction
    Date Received
    October 18, 2010
    Date of Event
    July 7, 2010
    Report Date
    September 30, 2010
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K063696
    Removal / Correction Number
    6000001-3/15/05-007-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) EVALUATION SUMMARY: THE CONDITION OF A COLLEAGUE INFUSION PUMP WITH FAILURE CODE 810:11 WAS CONFIRMED IN THE PUMP'S EVENT HISTORY BY A BAXTER SERVICE TECHNICIAN. THIS CONDITION WAS CAUSED BY THE PUMP'S AIR IN LINE PRINTED CIRCUIT BOARD BEING OUT OF CALIBRATION. THE AIR IN LINE PRINTED CIRCUIT BOARD WAS CALIBRATED TO CORRECT THIS CONDITION. THIS DEVICE IS A REMEDIATED COLLEAGUE PUMP WITH A USER INTERFACE MODULE SOFTWARE VERSION OF 6.13.90. SHOULD ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS DEVICE IS CURRENTLY IN THE PROCESS OF BEING EVALUATED. A FOLLOW-UP MEDWATCH WILL BE SUBMITTED UPON THE RECEIPT OF EVALUATION RESULTS OR IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4).BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH MDQ-CAPA-(B)(4).

    Description of Event or Problem · 1

    DURING REVIEW OF THE PUMP'S EVENT HISTORY, BAXTER (B)(4) DISCOVERED A COLLEAGUE INFUSION PUMP HAD EXPERIENCED FAILURE CODE 810:11, WHICH INTERRUPTED DELIVERY. THERE WAS NO REPORT OF PATIENT INJURY, MEDICAL INTERVENTION NECESSARY, OR ADVERSE REACTION IN ASSOCIATION WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE. THE USER INTERFACE MODULE SOFTWARE VERSION OF THIS PUMP IS CURRENTLY UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLEAGUE CXE VOLUMETRICINFUSION PUMP PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1